Healthy WomenNCT01879891
Exercise Intensity, Metabolic Rate and Insulin Sensitivity
A study testing Aerobic in people with Healthy Women, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The primary goal is to test the hypothesis high interval exercise increases energy expenditure and Insulin sensitivity more than 2 days of rest or moderate intensity exercise cumulatively over 23 hours during and following the exercise. Read more about this study
- Who is it for?
- Ages 19 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Women
- What is being tested?
- Aerobic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- May 1995to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy premenopausal African-American or Caucasian women ages 19 - 42
Who cannot join
- subjects cannot be smoking,
- taking medications which alter energy expenditure or fuel utilization,
- be diabetic or have a body mass index (BMI) less than 18 or more than 35.
- Also subjects cannot be pregnant or have cardiopulmonary disease.
Trial locations and contacts
1 site in 1 country.
About this study
The primary goal is to test the hypothesis high interval exercise increases energy expenditure and Insulin sensitivity more than 2 days of rest or moderate intensity exercise cumulatively over 23 hours during and following the exercise. Secondary goals are to evaluate exercise difficulty during moderate intensity exercise and high interval exercise as well as difficulty of activities of daily living and free living physical activity following rest, moderate intensity exercise and high interval exercise.
A secondary study is designed to evaluate potential mechanism. Hypotheses are that changes in muscle lipid metabolism, mitochondrial function, fat and cellular insulin signals will be increased following the high intensity interval exercise. In addition, these changes will be related to changes in insulin sensitivity and increases in protein metabolism and muscle damage.
- Conditions
- Healthy Women
- Being tested
- Aerobic
- Keywords
- Exercise Intensity, Metabolism, Insulin
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AerobicOther
Exercise training will consist of bicycle ergometer riding starting at 67% of heart rate max for 20 minutes. Exercise Intensity will be progressively increased every week until 80% of heart rate max for 40 minute sessions is reached.
| Study group | Role | What they receive |
|---|---|---|
| Non-Biopsy | Other | The Non-Biopsy group will complete a VO2 maximum test, are provided food 2 days prior to assessments, exercise in the metabolic chamber, have a Resting Energy Expenditure test, complete a DEXA and have blood drawn. This group will stay overnight in the metabolic chamber and have the clamp procedure. Exercise training is exactly the same for both groups.
Those who select the Non-Biopsy group, in lieu of the biopsy test, will complete an Activities of Daily Living (ADL) test that involves sub-maximal VO2 assessment. The participants will also be asked to where an accelerometer home for 4 consecutive days after the ADL test. Receives: Other: Aerobic |
| Biopsy | Other | The Biopsy group will also complete a VO2 maximum test, are provided food 2 days prior to assessments, exercise in the metabolic chamber, have a Resting Energy Expenditure test, complete a DEXA and have blood drawn. As with the Non-Biopsy group, this group will stay overnight in the metabolic chamber and have the clamp procedure. Exercise training is exactly the same for both groups. One week following the overnight metabolic chamber visit, participants in this group will undergo a muscle biopsy. This group will not complete the Activities of Daily Living (ADL) test nor will they be asked to wear an accelerometer. Receives: Other: Aerobic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Intensity
To test the hypothesis that high interval exercise increases energy expenditure and Insulin sensitivity more than 2 days of rest or moderate intensity exercise cumulatively over 23 hours during and following the exercise
Measured: 16 weeks
Secondary outcomes (1)
Exercise Difficulty
To evaluate exercise difficulty during moderate intensity exercise and high interval exercise as well as difficulty of activities of daily living and free living physical activity following rest, moderate intensity exercise and high interval exercise
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2013 (estimated)
- Study startMay 1995
- Primary completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy WomenStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gary Hunter, PhD, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01879891
- Sponsor's protocol ID
- 5R01DK049779-14
- Status last verified
- Oct 2016
- First submitted
- 13 Jun 2013
- Last updated
- 25 Oct 2016
- Results posted
- No
Publications
Fisher G, Tamhane A, Moellering DR, Behrens CE, Hunter GR. Association Between Antioxidant Capacity and Vascular Hemodynamics in Premenopausal Women Following Exercise Training. J Clin Hypertens (Greenwich). 2025 Apr;27(4):e70046. doi: 10.1111/jch.70046.
PubMed 40285505
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Intensity, Metabolic Rate and Insulin Sensitivity
- ClinicalTrials.gov ID
- NCT01879891
- Acronym / sponsor ID
- 5R01DK049779-14
- Conditions
- Healthy Women
- Keywords
- Exercise Intensity, Metabolism, Insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- May 1995
- Primary completion
- Aug 2016 (actual)
- First posted
- 18 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary goal is to test the hypothesis high interval exercise increases energy expenditure and Insulin sensitivity more than 2 days of rest or moderate intensity exercise cumulatively over 23 hours during and following the exercise. Secondary goals are to evaluate exercise difficulty during moderate intensity exercise and high interval exercise as well as difficulty of activities of daily living and free living physical activity following rest, moderate intensity exercise and high interval exercise.
A secondary study is designed to evaluate potential mechanism. Hypotheses are that changes in muscle lipid metabolism, mitochondrial function, fat and cellular insulin signals will be increased following the high intensity interval exercise. In addition, these changes will be related to changes in insulin sensitivity and increases in protein metabolism and muscle damage.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Biopsy | Other | Other: AerobicThe Non-Biopsy group will complete a VO2 maximum test, are provided food 2 days prior to assessments, exercise in the metabolic chamber, have a Resting Energy Expenditure test, complete a DEXA and have blood drawn. This group will stay overnight in the metabolic chamber and have the clamp procedure. Exercise training is exactly the same for both groups. Those who select the Non-Biopsy group, in lieu of the biopsy test, will complete an Activities of Daily Living (ADL) test that involves sub-maximal VO2 assessment. The participants will also be asked to where an accelerometer home for 4 consecutive days after the ADL test. |
| Biopsy | Other | Other: AerobicThe Biopsy group will also complete a VO2 maximum test, are provided food 2 days prior to assessments, exercise in the metabolic chamber, have a Resting Energy Expenditure test, complete a DEXA and have blood drawn. As with the Non-Biopsy group, this group will stay overnight in the metabolic chamber and have the clamp procedure. Exercise training is exactly the same for both groups. One week following the overnight metabolic chamber visit, participants in this group will undergo a muscle biopsy. This group will not complete the Activities of Daily Living (ADL) test nor will they be asked to wear an accelerometer. |
Who may qualify
- Ages
- 19 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy premenopausal African-American or Caucasian women ages 19 - 42
Key exclusion criteria (4 listed)
- subjects cannot be smoking,
- taking medications which alter energy expenditure or fuel utilization,
- be diabetic or have a body mass index (BMI) less than 18 or more than 35.
- Also subjects cannot be pregnant or have cardiopulmonary disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AerobicExercise training will consist of bicycle ergometer riding starting at 67% of heart rate max for 20 minutes. Exercise Intensity will be progressively increased every week until 80% of heart rate max for 40 minute sessions is reached. | Other | Biopsy, Non-Biopsy |
Primary outcome
Exercise Intensity
Time frame: 16 weeks
To test the hypothesis that high interval exercise increases energy expenditure and Insulin sensitivity more than 2 days of rest or moderate intensity exercise cumulatively over 23 hours during and following the exercise
1 secondary outcome
Exercise Difficulty
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- Derived from this study: PubMed 40285505Fisher G, Tamhane A, Moellering DR, Behrens CE, Hunter GR. Association Between Antioxidant Capacity and Vascular Hemodynamics in Premenopausal Women Following Exercise Training. J Clin Hypertens (Greenwich). 2025 Apr;27(4):e70046. doi: 10.1111/jch.70046.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic in people with Healthy Women, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise Intensity (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01879891, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2016.